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抗肿瘤坏死因子 α 治疗在脊柱关节炎患者中的有效性和药物生存:来自泰国风湿病预先授权登记处的分析。

Effectiveness and Drug Survival of Anti-Tumor Necrosis Factor α Therapies in Patients With Spondyloarthritis: Analysis From the Thai Rheumatic Disease Prior Authorization Registry.

机构信息

Division of Rheumatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University.

Division of Rheumatology, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine.

出版信息

J Clin Rheumatol. 2019 Jan;25(1):9-15. doi: 10.1097/RHU.0000000000000741.

DOI:10.1097/RHU.0000000000000741
PMID:29517554
Abstract

OBJECTIVE

This study aimed to evaluate the long-term effectiveness and safety of the first anti-tumor necrosis factor α therapy (TNFi) and to identify the associated factors of drug discontinuation in patients with spondyloarthritis.

METHODS

This was a medical records review study. Patients with spondyloarthritis who were prescribed the first TNFi between December 2009 and October 2014 in the Rheumatic Disease Prior Authorization registry were enrolled. Baseline clinical data were retrieved. The Cox proportional hazards model was used to identify factors associated with discontinuation of drugs.

RESULTS

Among 138 patients, 97 had ankylosing spondylitis (AS), and 41 had psoriatic arthritis (PsA). The effectiveness of TNFi in AS and PsA was 55% to 59% at 4 months and 75% to 96% at 3 years, as measured by a 50% decrease in the Bath Ankylosing Spondylitis Disease Activity Index from baseline. For PsA with peripheral arthritis, improvement of the joint count by 50% was observed in 61.8% of patients at 4 months and 100% at 3 years. Survival from TNFi was 63% for AS and 56% for PsA at 3 years. For AS, the factors associated with good response leading to discontinuation of TNFi were baseline patient global assessment 3 to 6/10 (hazard ratio [HR], 6.3) and the use of leflunomide (HR, 6.0) and infliximab (HR, 4.8). A good response (38.5%) was the most common cause of discontinuation of the first TNFi, followed by toxicity (28.2%), nonadherence (20.5%), and lack of effectiveness (12.8%).

CONCLUSIONS

Ankylosing spondylitis and PsA responded well to TNFi during the 3-year follow-up. The retention rate was approximately 60% for AS and PsA. A good response to the first TNFi was the most common reason for discontinuation.

摘要

目的

本研究旨在评估首项抗肿瘤坏死因子 α 治疗(TNFi)的长期疗效和安全性,并确定脊柱关节炎患者停药的相关因素。

方法

这是一项病历回顾性研究。在风湿病预先授权登记处,纳入 2009 年 12 月至 2014 年 10 月期间接受首项 TNFi 治疗的脊柱关节炎患者。检索基线临床数据。采用 Cox 比例风险模型确定与药物停药相关的因素。

结果

在 138 例患者中,97 例为强直性脊柱炎(AS),41 例为银屑病关节炎(PsA)。以基线 Bath 强直性脊柱炎疾病活动指数(BASDAI)下降 50%衡量,在 4 个月时,TNFi 在 AS 和 PsA 中的疗效分别为 55%至 59%,在 3 年时为 75%至 96%。对于伴外周关节炎的 PsA,在 4 个月时,61.8%的患者关节计数改善 50%,而在 3 年时则为 100%。在 3 年时,AS 和 PsA 患者从 TNFi 中生存的比例分别为 63%和 56%。对于 AS,导致 TNFi 停药的良好反应的相关因素包括基线患者总体评估 3 至 6/10(风险比[HR],6.3)和使用来氟米特(HR,6.0)和英夫利昔单抗(HR,4.8)。良好的反应(38.5%)是停用首项 TNFi 的最常见原因,其次是毒性(28.2%)、不依从(20.5%)和无效(12.8%)。

结论

在 3 年随访期间,AS 和 PsA 对 TNFi 反应良好。AS 和 PsA 的保留率约为 60%。对首项 TNFi 的良好反应是停药的最常见原因。

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